仿制药质量一致性评价及有关建议(3)
参考文献
[1] 朱全刚, 潘勇华, 樊毅, 等. 8种格列美脲片剂的质量比较[J]. 中国临床药学杂志, 2012, 21(1): 33-37.
[2] Attorrese G, Massi-Benedetti M. Quality and behavior of glimepiride generics versus Amaryl under stressed conditions[J]. Diabetes Technol Ther, 2007, 9(3): 287-296.
[3] U.S. Food and Drug Administration. A brief history of the Center for Drug Evaluation and Research [EB/OL]. [2018-11-19]. https://www.fda.gov/AboutFDA/History/VirtualHistory/ HistoryExhibits/ucm325199.htm.
[4] 王青宇, 楊悦. 中美日仿制药一致性评价政策比较研究[J]. 中国药房, 2017, 28(25): 3457-3460.
[5] 谢沐风. 对《日本版橙皮书——溶出一致、临床疗效一致》的解读——兼论我国口服固体制剂仿制药质量评价[J]. 药品评价, 2017, 14(4): 18-21, 58.
[6] Gallelli L, Palleria C, De Vuono A, et al. Safety and efficacy of generic drugs with respect to brand formulation[J]. J Pharmacol Pharmacother, 2013, 4(Suppl 1): S110-S114.
[7] 王素珍, 李荣荣, 岳雪, 等. 辛伐他汀片原研药与仿制药质量比较和体外一致性评价[J]. 医药导报, 2017, 36(A01): 70-73.
[8] 李惠云, 郭瑞臣. 硝苯地平原研与仿制口服制剂体外释放度的对比研究[J]. 中国医药指南, 2014, 12(25): 91-92.
[9] Videau JY. Making medicines safe [J]. Bull World Health Organ, 2001, 79(2): 87., 百拇医药(黄仲义 李光慧)
[1] 朱全刚, 潘勇华, 樊毅, 等. 8种格列美脲片剂的质量比较[J]. 中国临床药学杂志, 2012, 21(1): 33-37.
[2] Attorrese G, Massi-Benedetti M. Quality and behavior of glimepiride generics versus Amaryl under stressed conditions[J]. Diabetes Technol Ther, 2007, 9(3): 287-296.
[3] U.S. Food and Drug Administration. A brief history of the Center for Drug Evaluation and Research [EB/OL]. [2018-11-19]. https://www.fda.gov/AboutFDA/History/VirtualHistory/ HistoryExhibits/ucm325199.htm.
[4] 王青宇, 楊悦. 中美日仿制药一致性评价政策比较研究[J]. 中国药房, 2017, 28(25): 3457-3460.
[5] 谢沐风. 对《日本版橙皮书——溶出一致、临床疗效一致》的解读——兼论我国口服固体制剂仿制药质量评价[J]. 药品评价, 2017, 14(4): 18-21, 58.
[6] Gallelli L, Palleria C, De Vuono A, et al. Safety and efficacy of generic drugs with respect to brand formulation[J]. J Pharmacol Pharmacother, 2013, 4(Suppl 1): S110-S114.
[7] 王素珍, 李荣荣, 岳雪, 等. 辛伐他汀片原研药与仿制药质量比较和体外一致性评价[J]. 医药导报, 2017, 36(A01): 70-73.
[8] 李惠云, 郭瑞臣. 硝苯地平原研与仿制口服制剂体外释放度的对比研究[J]. 中国医药指南, 2014, 12(25): 91-92.
[9] Videau JY. Making medicines safe [J]. Bull World Health Organ, 2001, 79(2): 87., 百拇医药(黄仲义 李光慧)